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A Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392232
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Brief Summary:

Purpose of Study

• The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19.


Condition or disease Intervention/treatment Phase
Coronavirus COVID-19 Convalescent Plasma Drug: Convalescent Plasma Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-Randomized, single arm study of convalescent plasma treatment of covid 19.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convalescent Plasma Drug: Convalescent Plasma

• Investigational Product

o COVID-19 convalescent plasma will be obtained from an FDA-registered blood establishment (Hoxworth) that follows donor eligibility criteria and donor qualifications as outlined in section III.C.I of the Investigational COVID-19 Convalescent Plasma Guidance for Industry.





Primary Outcome Measures :
  1. Survival Rate [ Time Frame: At 28 Days ]
    % patients who survived



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

• Eligibility Criteria

  • Participants will be 16 years or older.
  • COVID-19 infection demonstrated via SARS-CoV-2 PCR testing.
  • Admitted to the hospital for treatment of Covid 19.
  • Patients must have severe/high risk disease as defined by the presence of any one of the following:

Respiratory frequency ≥ 25/minute Oxygen saturation ≤ 93% on room air Partial pressure of arterial oxygen to fraction of inspired oxygen ration < 300, or pulse oximetric saturation to fraction of inspired oxygen ratio < 315.

Lung infiltrates > 50% within 24-48 hours of admission on Chest X-Ray or, Ferritin > 1000 or absolute lymphocyte count < 600 or D-Dimer > 1.00

  • ABO Blood Type available.
  • Pregnant women will be permitted to participate in this study.

    • Exclusion criteria

  • Previous history of life threatening or severe adverse reactions to transfusion blood products..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392232


Contacts
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Contact: William Judd, MBA, MHA(C.) 513 865 5020 William_Judd@TriHealth.com

Locations
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United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Thomas E. Coyle, MD TriHealth Inc.
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT04392232    
Other Study ID Numbers: 20-045
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases